Evaluating B007 for treating generalized myasthenia gravis

A Randomized, Double-blind, Placebo-controlled, Multicenter Phase II/III Clinical Study to Evaluate the Efficacy and Safety of B007 in Subjects With Generalized Myasthenia Gravis

This study is testing a new treatment called B007 to see if it can help people with generalized myasthenia gravis feel better.

Quick facts

• Phase: Phase2; Phase3
• Study type: Interventional
• Enrollment: 104 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Shanghai Jiaolian Drug Research and Development Co., Ltd (Industry-sponsored)
• Locations: 18 sites (Beijing and 17 other locations)
• Trial ID: NCT06447597 on ClinicalTrials.gov

What this trial studies

This clinical study aims to assess the efficacy and safety of B007 in patients diagnosed with generalized myasthenia gravis. Participants will be randomly assigned to receive either B007 or a placebo, with the goal of determining how well B007 improves symptoms associated with this condition. The study will include individuals who have tested positive for specific antibodies related to myasthenia gravis and have a certain level of disease severity. The trial will be conducted across multiple locations to gather diverse data on the treatment's effectiveness.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals with a confirmed diagnosis of generalized myasthenia gravis who meet specific antibody and severity criteria.

Not a fit: Patients with mild or severe forms of myasthenia gravis, or those with certain medical histories that disqualify them, may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from generalized myasthenia gravis.

How similar studies have performed: While this approach is being evaluated in this study, similar interventions have shown promise in other trials targeting autoimmune conditions, suggesting potential for success.

Eligibility criteria

Inclusion Criteria:

1. Sign informed consent form;
2. Subjects with generalized myasthenia gravis;
3. Serum AchR(Acetylcholine receptor)-Ab or MUSK-Ab was positive during screening;
4. MG-ADL ≥5 at screening and baseline;
5. Before randomization, subjects received at least one gMG stable dose of SoC, and maintain a stable dose throughout the test;
6. Subjects agree to use effective contraceptive methods for contraception from signing the informed consent form to 1 year after the last dose. Female subjects considered fertile by the investigator must have negative serum pregnancy tests before the first dose.

Exclusion Criteria:

1. Subjects with MGFA I and V type;
2. Subjects usingprescribed drugs;
3. Subjects with a prescribed disease or history of disease;
4. The subjects has prescribed examination abnormalities that are assessed as unsuitable for participation in the study by the investigator;
5. Known history of severe allergic reaction to humanized monoclonal antibodies, or known allergy to any component of B007;
6. Subjects who received live vaccine at the specified time before the first dose and are expected to receive the vaccine at the specified time after the last dose;
7. Subjects who have received major surgery or participated in other clinical trials within the prescribed time before screening;
8. Pregnant and lactating women;
9. Fertile female subjects do not agree to use effective contraception from signing the informed consent form to 1 years after the last dose.
10. Sexually active male subjects who do not intend to use an effective contraceptive method during the trial period or within1 years after the last dose, or male subjects who plan to donate sperm during the trial or within 1 year after the last dose;
11. A history of alcohol or drug abuse within the past 12 months;
12. Other conditions deemed unsuitable for participation in this study by the researchers.

Where this trial is running

Beijing and 17 other locations

• Peking University First Hospital — Beijing, China (Recruiting)
• The First Bethune Hospital of Jilin University — Changchun, China (Recruiting)
• Xiangya Hospital Central South University — Changsha, China (Recruiting)
• Sichuan Provincial People's Hospital — Chengdu, China (Recruiting)
• Nanfang Hospital, Southern Medical University — Guangzhou, China (Recruiting)
• The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, China (Recruiting)
• Shandong Provincial Qianfoshan Hospital — Jinan, China (Recruiting)
• Shandong University Cheeloo College of Medicine — Jinan, China (Recruiting)
• First People's Hospital of Yunnan Province — Kunming, China (Recruiting)
• Jiangxi Provincial People's Hospital — Nanchang, China (Recruiting)
• The Second Affiliated Hospital of Nanchang University — Nanchang, China (Recruiting)
• Shandong University Cheeloo College of Medicine — Qingdao, China (Recruiting)
• Huashan Hospital, Fudan University — Shanghai, China (Recruiting)
• Shenzhen Hospital of University of Hong Kong — Shenzhen, China (Recruiting)
• Renmin Hospital of Wuhan University — Wuhan, China (Recruiting)
• Tongji Medical College of HUST — Wuhan, China (Recruiting)
• Tangdu Hospital — Xi'an, China (Recruiting)
• Affiliated Hospital of Zunyi Medical College — Zunyi, China (Recruiting)

Study contacts

• Study coordinator: Jianying Xi

Conditions Generalized Myasthenia Gravis